CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Vancomycin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03476317
NCT03476317Phase 2Completed
CompareCT.gov

An Open-Label Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

Children's Hospital of Philadelphia·interventional·Posted Mar 26, 2018·Updated Feb 9, 2022

In Brief

A Phase 2 clinical trial evaluating Vancomycin, Neomycin, and 3 other interventions for Crohn Disease. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) or indeterminate colitis (IBDU) that is refractory to conventional, immunosuppressive therapy. In addition, the study will determine the effect of PEG lavage alone on fecal calprotectin and gut microbiota in patients who are undergoing a PEG lavage for clinical care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesUnited States
CollaboratorsUniversity of Pennsylvania, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 26, 2018
Enrollment StartJul 12, 2018
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.3 years ago

Interventions

Vancomycindrug

Oral suspension 4 times daily (Day 1-14)

Neomycindrug

Oral three times daily (Days 1-3)

Ciprofloxacindrug

Oral twice daily (Days 4-14)

Polyethylene Glycol 3350drug

Dissolved in Gatorade on day 2

Fluconazoledrug

Orally once daily (Day 1-14)